Cannabinoid Profile Investigation of Vapourized Cannabis in Patients With Osteoarthritis of the Knee

Summary

Primary Objective:

\- To determine the analgesic dose-response characteristics of vapourized cannabinoids with varying degrees of delta-9-tetrahydrocannabiol (THC)/ Cannabidiol (CBD) ratios.

Secondary Objectives:

* To compare functional changes and patient preferences of different cannabinoid (THC, CBD) profiles in patients with OA (Osteoarthritis);
* To describe the Pharmacokinetics (PK) of vapourized cannabis of differing cannabinoid profiles in patients with OA;
* To explore the short term safety of vapourized cannabis with different cannabinoid profiles.
* To describe the incidence and severity of psychoactive events.

Conditions

• Osteoarthritis, Knee

Interventions

DRUG

Cannabis

Cannabis sativa L. subsp. indica, variety indica blends of flowering heads that have been air-dried, milled, destemmed and fine ground, stored in glass vials with aluminum caps in 100 mg dose size.

DEVICE

Volcano® Medic Vapourizer

Volcano® Medic vapourizer is licensed for medical administration of cannabis in Canada March 2010 (Licence No. 82405). The contents of a vial of drug product formulation will be transferred to the Volcano® Medic's filling chamber (sample-holder) equipped top and bottom with fine wire mesh to retain the finely ground material. The filling chamber will be placed atop the main body of the unit and then have a, 12.5 L, heat-resistant Medic Valve balloon affixed. Active components are vapourized at 190 °C. The ensuing vapour is captured in the balloon and inhaled by the study subject using a standardized inhalation technique.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre

  collaborator OTHER

• Dalhousie University

  collaborator OTHER

• Algorithme Pharma Inc

  collaborator INDUSTRY

• Research Institute of the McGill University Health Center

  collaborator UNKNOWN

• Prairie Plant Systems Inc.

  lead INDUSTRY

Principal Investigators

• Mark Ware, MD · McGill University Health Centre/Research Institute of the McGill University Health Centre

• Mary Lynch, MD · Queen Elizabeth II Health Science Centre

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-06-30

Primary Completion

2018-12-31

Completion

2019-06-30

Countries

• Canada

Study Locations